Hormone Changes in Women With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Receiving Erlotinib

April 14, 2011 updated by: Northwestern University

Evaluation of Hormonal Changes in Women on Erlotinib Therapy

Studying samples of blood in the laboratory from patients receiving erlotinib may help doctors learn more about the effects of erlotinib on hormone levels.

This clinical trial is looking at hormone changes in women with stage IIIB or stage IV non-small cell lung cancer receiving erlotinib.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients undergo a dermatology evaluation and complete the Polycystic Ovarian Syndrome (PCOS) research study questionnaire once. Blood samples are collected after an overnight fast. Samples are analyzed for circulating levels of total and bioavailable testosterone, dehydroepiandrosterone sulfate, and sex hormone binding globulin. Serum luteinizing hormone, follicle stimulating hormone, fasting glucose, and insulin levels are also assessed.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Northwestern University, Northwestern Medical Faculty Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Subjects have advanced nonsmall cell lung cancer and have been taking erlotinib as part of anticancer therapy for at least 3 months.

Description

  • Histologically confirmed non-small cell lung cancer

    • Stage IIIB (effusion) or stage IV disease
  • Must be receiving daily erlotinib hydrochloride for more than 3 months
  • Must have hirsutism, acne, androgenic alopecia, amenorrhea, truncal weight gain, or other clinical phenotype associated with syndrome of androgen excess

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
questionnaire and laboratory biomarker analysis
Subjects with advanced non-small cell lung cancer and take erlotinib as part of their anticancer therapy for at least 3 months. Subjects have had some changes in hair growth, acne or menses (periods) that might be a side effect of erlotinib. Subjects will complete a questionnaire and blood collected for biomarker analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of hyperandrogenemia
Time Frame: One approximate 30 minute visit
We will determine if hyperandrogenemia is present in women with nonsmall cell lung cancer who are taking erlotinib.
One approximate 30 minute visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatologic manifestations
Time Frame: One approximate 30 minute visit
We will describe the dermatologic manifestations of erlotinib in women
One approximate 30 minute visit
Changes in body habitus and patterns of hair loss
Time Frame: One approximate 30 minute visit
We will describe changes in body habitus and patterns of hair loss from women on erlotinib.
One approximate 30 minute visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Jyoti D. Patel, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

April 15, 2011

Last Update Submitted That Met QC Criteria

April 14, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 07CC4
  • STU00001887 (Other Identifier: Northwestern University IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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